Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
Primary Purpose
COVID-19, SARS-CoV-2
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
COVI-VAC
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
- Body mass index (BMI) ≤ 35 kg/m2
- In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator
- Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Exclusion Criteria:
- Residents of residential care facilities
- Pregnant or lactating women
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
Sites / Locations
- HMR
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COVI-VAC
Arm Description
COVI-VAC Nose Drops
Outcomes
Primary Outcome Measures
Humoral Immunogenicity
IgG Titer measured by ELISA on day 1
Humoral Immunogenicity
IgG Titer measured by ELISA on day 29
Humoral Immunogenicity
IgG Titer measured by ELISA on day 181
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 181
Secondary Outcome Measures
Vaccine and Virus Shedding
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4
Vaccine and Virus Shedding
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05233826
Brief Title
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
Official Title
Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Codagenix, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo.
During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVI-VAC
Arm Type
Experimental
Arm Description
COVI-VAC Nose Drops
Intervention Type
Biological
Intervention Name(s)
COVI-VAC
Intervention Description
Intranasal, live attenuated vaccine against SARS-CoV-2
Primary Outcome Measure Information:
Title
Humoral Immunogenicity
Description
IgG Titer measured by ELISA on day 1
Time Frame
Day 1
Title
Humoral Immunogenicity
Description
IgG Titer measured by ELISA on day 29
Time Frame
Day 1
Title
Humoral Immunogenicity
Description
IgG Titer measured by ELISA on day 181
Time Frame
Day 181
Title
Humoral Immunogenicity measured by neutralizing antibodies
Description
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Time Frame
Day 1
Title
Humoral Immunogenicity measured by neutralizing antibodies
Description
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Time Frame
Day 29
Title
Humoral Immunogenicity measured by neutralizing antibodies
Description
neutralising antibody titer measured by microneutralisation assay in serum on day 181
Time Frame
Day 181
Secondary Outcome Measure Information:
Title
Vaccine and Virus Shedding
Description
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4
Time Frame
Day 4
Title
Vaccine and Virus Shedding
Description
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
Body mass index (BMI) ≤ 35 kg/m2
In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator
Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Exclusion Criteria:
Residents of residential care facilities
Pregnant or lactating women
Inadequate venous access for repeated phlebotomy
History of confirmed or suspected SARS-CoV-2 infection
Facility Information:
Facility Name
HMR
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
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